Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices
The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion.
Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to help attendees understand the "off-label statute" and its legal implications. It is is also designed to help attendees operate within off-label promotional guidance, or framework.
It is illegal to market a device for the purpose that it has not been approved for by the FDA. This webinar provides guidelines set by the FDA for off-label promotion.
Areas Covered in the Session:
Who Will Benefit:
- Off-label statute
- Label claims
- Allowable reprints
- Promotional compliance
- FDCA: The law
- Sales executives in Medical Device
- Regulatory Affairs personnel
- Corporate counsel
- Quality personnel